POS0918 EVALUATION OF SPINAL RADIOGRAPHIC PROGRESSION IN PATIENTS WITH RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS RECEIVING IXEKIZUMAB THERAPY OVER 2 YEARS

D. Van der Heijde, M. Østergaard, J. D. Reveille, X. Baraliakos, A. Kronbergs, D. Sandoval, X. Li, H. Carlier, D. Adams, W. P. Maksymowych
2021 Annals of the Rheumatic Diseases  
Background:It is important to understand the potential effect long-term therapy with biologics can have on structural changes in the spine among patients with active radiographic axial spondyloarthritis (r-axSpA, ankylosing spondylitis).Objectives:We examined radiographic progression in the spine among patients with active r-axSpA treated with ixekizumab, an IL-17A antagonist, for 2 years, and potential predictors of spinal radiographic progression.Methods:Patients with active r-axSpA,
more » ... naive (COAST-V, NCT02696785) or with prior experience with a maximum of 2 TNF inhibitors (COAST-W, NCT02696798), received 80 mg ixekizumab every 2 or 4 weeks for 2 years (108 weeks, of which 56 weeks were the COAST-Y extension study, NCT03129100). Mean change from baseline of modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) (average score from 2 selected readers, blinded for time order) for patients treated with ixekizumab for 2 years with data at both baseline and year 2 is presented (N=230; 54% of total randomized patients). Non-progression is presented for all patients and subgroups based on TNFi-experience. Predictors were identified in multivariate logistic regression models with stepwise selection criteria of p-value <0.1. All data are observed.Results:At baseline, patients (N=230) were predominately male (82%) with an average age of 43 years, mean symptom duration of 16 years, 52% were TNFi-experienced, mean (SD) ASDAS score was 4.0 (0.7), most were HLA-B27 positive (87%) and 40% had syndesmophytes (identified by both selected readers at the same location). Baseline mSASSS (SD) was 11.0 (16.3) and change from baseline at year 2 of treatment was 0.3 (1.8) (Table 1). The proportion of non-progressors (mSASSS change from baseline <2) over 2 years was 89.6% (total IXE [all patients]), 90.9% (biologic-naive) and 88.3% (TNFi-experienced), and, if defined as mSASSS change from baseline ≤0, 75.7% (total IXE [all patients]), 78.2% (biologic-naive) and 73.3% (TNFi-experienced) (Table 1). Predictors of structural progression at year 2 (mSASSS change >0) were age, baseline syndesmophytes, HLA-B27 status and gender (Table 1). Week 52 inflammation in MRI SPARCC spine was also identified as a predictor for structural progression at year 2 in a separate model for patients from COAST-V where MRI measures were available at baseline and Week 52 (N=109).Conclusion:The majority of patients treated with ixekizumab for 2 years did not show radiographic progression, and the overall mean progression was low. Similar levels of non-progression were observed in biologic-naive patients and patients previously exposed to TNFis. Predictors were generally consistent with previous studies.Table 1.Spinal radiographic changes for patients with active r-axSpA treated with ixekizumab for 2 yearsChange in mSASSS at year 2All patientsaN=230Biologic-naiveN=110TNFi-experiencedN=120 Baseline mSASSS, mean (SD)11.0 (16.3)10.1 (15.5)11.7 (17.0) Change at year 2, mean (SD)0.3 (1.8)0.3 (2.0)0.4 (1.6) Change in total mSASSS <2, n (%)206 (89.6)100 (90.9)106 (88.3) Change in total mSASSS ≤0, n (%)174 (75.7)86 (78.2)88 (73.3)Multivariable logistic regression modelPrediction for change in total mSASSS >0, OR (95% CI), p-valueAll patientsa,bN=228 Age (≥40 years vs. <40 years)2.97 (1.41, 6.28)p=0.004c Baseline syndesmophytesb (yes vs. no)2.31 (1.18, 4.54)p=0.015c Baseline HLA-B27 (positive vs. negative)3.78 (1.04, 13.75)p=0.044c Gender (male vs. female)3.16 (1.01, 9.86)p=0.047c Baseline ASDAS state (>3.5 vs. [2.1, 3.5])2.26 (0.96, 5.34)p=0.063aCombined ixekizumab group of Q2W and Q4W patients with baseline and year-2 mSASSS databIdentified by both selected readers at the same location (2 patients were not evaluable by both readers)cp<0.05Abbreviations: ASDAS=Assessment of Disease Activity, CI=confidence interval, IXE=ixekizumab, mSASSS=modified Stoke Ankylosing Spondylitis Spinal Score, OR=odds ratio, Q2W=every 2 weeks, Q4W=every 4 weeks, SD=standard deviation, TNFi=tumor necrosis factor inhibitorDisclosure of Interests:Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma, Employee of: Director of Imaging Rheumatology bv., Mikkel Østergaard Consultant of: AbbVie, BMS, Boehringer-Ingelheim, Eli Lilly and Company, Janssen, Merck, Pfizer, Roche, UCB, Celgene, Sanofi, Regeneron, Novartis, Grant/research support from: AbbVie, BMS, Merck, UCB, Celgene, Novartis, John D Reveille Paid instructor for: UCB, Eli Lilly and Company, Consultant of: UCB, Eli Lilly and Company, Pfizer, Novartis, Grant/research support from: Janssen, Eli Lilly and Company, Xenofon Baraliakos Speakers bureau: Abbvie, BMS, Lilly, Janssen, Novartis, MSD, Pfizer, Galapagos, Gilead, UCB, Paid instructor for: Abbvie, BMS, Lilly, Janssen, Novartis, MSD, Pfizer, Galapagos, Gilead, UCB, Consultant of: Abbvie, BMS, Lilly, Janssen, Novartis, MSD, Pfizer, Galapagos, Gilead, UCB, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Xiaoqi Li Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Hilde Carlier Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Walter P Maksymowych Speakers bureau: Abbvie, Janssen, Novartis, Pfizer, UCB, Consultant of: Abbvie, Boehringer, BMS, Eli Lilly and Company, Novartis, Pfizer, UCB, Grant/research support from: Abbvie, Novartis, Pfizer
doi:10.1136/annrheumdis-2021-eular.1620 fatcat:oqnf2mjlxrc4lntq3v53hp3v4u